scholarly journals Lyophilization biologicals products. Equipment. Technology. Validation.

2021 ◽  
Author(s):  
E.S. Serbis ◽  
I.N., Matveeva ◽  
V. I. Eremets
Keyword(s):  
Industrial Production ◽  
Freeze Drying ◽  
Heating Temperature ◽  
Liquid Product ◽  
Integrated Approach ◽  
Maximum Temperature ◽  
Drying Process ◽  
Entire Volume ◽  
Freeze Dried

Тhe aseptic process of industrial production of sterile lyophilized biological products is completed by one of the critical stages of the technological process, the freeze-drying. GOST R ISO 13408-3-2011 defines the term lyophilization as a synonym for the sublimation. Sublimation - the physical process on which the freeze-drying method is based. This paper discusses the issues of freeze drying that engineers and biologists, production technologist, designers of dry preparations, and quality specialists face with. Freeze-drying consists of three stages: freezing, freeze-drying and drying. Each stage has its own critical points, input and output parameters. The task of the developer of freeze-drying technology is to determine the need for each parameter and the sufficiency of their quantity. Equipment, technology and regulatory documents are considered as interdependent elements that make up freeze drying as a system. An integrated approach to the freeze-drying process includes the development of modes, equipment control, and internal documentation. The key parameters of the process are the qualitative and quantitative characteristics (reference values, measurement procedures, acceptable range of values) of the semi-finished liquid product and the finished freeze-dried product. Characteristics of the semi-finished liquid product are the temperature of complete crystallization; upper and lower eutectic temperatures; maximum permissible heating temperature (thermo-lability); density; specific (biological) activity. Freeze-drying process characteristics are: at the freezing stage - reaching the temperature of complete crystallization in the entire volume of the material received for drying; at the sublimation stage - maintaining the temperature in the dried material in the range between the lower and upper eutectic temperatures (without going beyond the upper); at the drying stage - reaching the maximum temperature in the material. The duration of each stage depends on the vial in which the dried material is packed, the volume of packaging, and the features of heat, mass, and energy exchange in the sublimation plant. Standard operating procedures (SOPs) should be designed with these features in mind. For example, for different packages (2ml or 10ml) in vials of the same volume, or for the same packaging in vials of different volumes, for example, 2ml in vial of 10-ml or 20-ml, separate SOPs are required in each case. In the current practice of industrial production, the quality of the lyophilized product is evaluated by humidity (GOST 24061-2012). In our work, to assess the quality of the process, we measured the decrease in the mass of liquid material during drying. We recommend measure both indicators, since they complement each other.

scholarly journals THE DIFFERENCE OF TENSILE STRENGTH AND YIELD FIBRINOGEN ON FIBRIN GLUE PREPARATIVE BY CRYOPRESIPITATE WITH AND WITHOUT FREEZE DRYING METHODS

2019 ◽  
Vol 25 (3) ◽  
pp. 349
Author(s):  
Brilliant Margalin ◽  
S. P. Edijanto ◽  
Paulus B. Notopuro
Keyword(s):  
Tensile Strength ◽  
Fibrin Glue ◽  
Freeze Drying ◽  
Drying Methods ◽  
Drying Process ◽  
Freeze Dried ◽  
Significant Difference ◽  
Fibrinogen Content

Fibrin glue is a useful biological product to stop bleeding, adhesive tissue and accelerate wound healing. Preparation of Fibrin Glue requires fibrinogen and thrombin components. The routine cryoprecipitation method performed at the Blood Bank can be used to improve the quality of the fibrinogen component. The Freeze Drying process can increase the retention time of plasma products at room temperature. Yield Fibrinogen and Tensile Strength is a quantitative and qualitative parameter of preparation quality of fibrin glue. This study focused on finding differences between Tensile Strength and Yield Fibrinogen on fibrin glue preparative by cryoprecipitate with and without freeze drying methods.This study is in vitro laboratory experiments design by comparing the Yield Fibrinogen and Tensile Strength of fibrin glue preparation from cryoprecipitic plasma with and without freeze dried process. The results were analyzed comparatively using paired T test.The plasma fibrinogen content of the sample was 237.66 ± 67.10 mg / dL. The fibrinogen content of the cryoprecipitate component without freeze drying process was 327.74 ± 103.42 mg / dL with a yield fibrinogen of 1.38 ± 0.25. The fibrinogen content of the cryoprecipitate component with freeze drying process was 251.20 ± 103.91 mg / dL with yield fibrinogen 1.04 ± 0.25. Tensile strength of fibrin glue from cryoprecipitate without freeze drying process was found to average 0.52 ± 0.18. Tensile strength of fibrin glue from cryoprecipitate with freeze drying process was found to average 0.33 ± 0.12. There was a significant difference between yield fibrinogen and tensile strength of fibrin glue preparation of cryoprecipitation method with and without freeze dried process.There is a significant difference on yields fibrinogen and tensile strength in the preparation of fibrin glue by the freeze drying process which is probably due to changes in the structure and function of fibrinogen proteins.

scholarly journals ASSESSMENT OF FREEZING PRE-TREATMENTS FOR THE FREEZE DRIED OF APPLE SLICES

2013 ◽  
Vol 17 (2) ◽  
pp. 3-14 ◽  
Author(s):  
Tamás Antal ◽  
László Sikolya ◽  
Benedek Kerekes
Keyword(s):  
Water Activity ◽  
Freeze Drying ◽  
Color Difference ◽  
Freezing Rate ◽  
Slow Freezing ◽  
Drying Process ◽  
Drying Time ◽  
Freeze Dried ◽  
Apple Slices

Abstract The effect of freezing rate on the quality of dried Jonagold and Idared was studied. Apple slices underwent various pre-treatments, i.e. freezing in household freezer (freezing rate: 0,5 °C/min), contact plate freezing (2 °C/min) and vacuum-freezing (3 °C/min). The quality of the freeze dried product was then evaluated in terms of water activity, hardness, color and rehydration. The freezing in household freezer (slow freezing rate) significantly reduces the duration of the freeze drying process and consequently the process costs. The slow freezing rate allows the growth of large ice crystals at the beginning of the freeze-drying process, this fact should consequently lead to larger pores and injured cell walls and thus to shorter freeze drying time. Quality of the freezing in household freezer product was assessed as higher than the quality of the other freezing pre-treated material. Slow freezing rate resulted softer texture and higher rehydration capacity, than that of other pre-treated samples. In all cases, slow freezing lead to lower final moisture content, total color difference and water activity.

scholarly journals Evaluation of freezing pre-treatments for the lyophilisation of apple

2013 ◽  
Vol 5 (1) ◽  
pp. 56-68
Author(s):  
Tamás Antal ◽  
László Sikolya ◽  
Benedek Kerekes
Keyword(s):  
Water Activity ◽  
Freeze Drying ◽  
Ice Crystals ◽  
Freezing Rate ◽  
Slow Freezing ◽  
Drying Process ◽  
Drying Time ◽  
Freeze Dried ◽  
Apple Slices

Abstract The effect of freezing rate on the quality of dried Jonagold and Idared (Malus domestica Borkh.) was studied. Apple slices underwent various pre-treatments, i.e. freezing in household freezer (freezing speed/rate: 0,5◦C/min), contact plate freezing (2◦C/min) and vacuumfreezing (3◦C/min). The quality of the freeze-dried product was then evaluated in terms of water activity (aw), hardness, color and rehydration. The texture and color experiments were carried out with texture analyser and colorimeter. The aw of apple slices was measured by aw apparatus. It was found that drying time was influenced by freezing rate. The freezing in household freezer (slow freezing rate) significantly reduces the duration of the freeze-drying process and consequently the process costs. The slow freezing rate allows the growth of large ice crystals at the beginning of the freeze-drying process; this fact should consequently lead to larger pores and injured cell walls and thus to shorter freeze-drying time. Quality of the freezing in household freezer product was assessed as higher than the quality of the other freezing pre-treated material. Slow freezing rate resulted softer texture and higher rehydration capacity than that of other pre-treated samples. In all cases, slow freezing speed lead to lower final moisture content, total color difference and water activity. Freeze-dried samples prepared with higher freezing rates (3◦C/min) were the most white in color because small pores, originated by sublimation of small ice crystals formed by fast freezing.

Drying characteristics and product quality of whole blueberry pulp in vacuum drying process

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Lijuan Zhao ◽  
Yonghuan Li ◽  
Hui Xie ◽  
Jianliang Zhang ◽  
Zhonghua Wu
Keyword(s):  
Freeze Drying ◽  
Heating Temperature ◽  
Convective Drying ◽  
Vacuum Drying ◽  
Operating Pressure ◽  
Drying Process ◽  
Drying Time ◽  
Drying Characteristics ◽  
Freeze Dried ◽  
Monomeric Anthocyanins

Abstract A pilot-scale vacuum dryer with visualization system was used to study the drying characteristics of the whole blueberry pulp. The heating temperature, operating pressure and initial material thickness had significant effects on the drying characteristics and the retentions of total monomeric anthocyanins and vitamin C in dried blueberry powder (P < 0.05). According the heat transfer mode inside the material, the whole drying process could be divided into three periods: the boiling drying period, the convective drying period, and the conductive drying period. Most of water in the material was evaporated in the boiling and convective drying period. Considering the drying characteristics and dried product quality comprehensively, an optimal drying condition for whole blueberry pulp were: heating temperature 70 °C, operating pressure 1 kPa, and the initial material thickness 5 mm. It further compared the drying time, nutrients retention, hygroscopicity and microstructure of the product obtained by vacuum and vacuum freeze drying. The drying time of vacuum drying (1.2 h) was much shorter than that of vacuum freeze drying (44 h); the retentions of the total monomeric anthocyanins and vitamin C in dried blueberry powder of vacuum drying (67.9, 46.7%) were lower than that of vacuum freeze drying (79.0, 85.8%); while the hygroscopicity of vacuum dried powder was less than that of the freeze-dried product. The SEM images displayed that the surface of the vacuum-dried blueberry powder was porous, and the vacuum freeze-dried product was lamellar.

scholarly journals The Quality of Red Bell Pepper Subjected to Freeze-Drying Preceded by Traditional and Novel Pretreatment

Foods ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 226
Author(s):  
Katarzyna Rybak ◽  
Artur Wiktor ◽  
Dorota Witrowa-Rajchert ◽  
Oleksii Parniakov ◽  
Małgorzata Nowacka
Keyword(s):  
Freeze Drying ◽  
Bell Pepper ◽  
Total Phenolic ◽  
Thermal Methods ◽  
Drying Time ◽  
Freeze Dried ◽  
Dehydration Processes ◽  
Vacuum Freezing ◽  
Better Than

It has been demonstrated previously in the literature that utilization of PEF or a combination of a pulsed electric field (PEF) and ultrasounds (US) can facilitate dehydration processes and improve the quality of dried products even better than the application of thermal methods such as blanching. The aim of the study was to evaluate the quality of red bell pepper subjected to freeze-drying preceded by blanching or PEF or US treatment applied in a single and combined mode. Furthermore, the freeze-drying was preceded by shock freezing or vacuum freezing performed inside the freeze-dryer as a result of pressure drop during the first stage of freeze-drying. All of the analyzed technological variants enhanced the drying kinetics when compared to the intact material. Freeze-dried bell pepper subjected to non-thermal pretreatment exhibited higher vitamin C, total phenolic and carotenoids content than blanched material despite the fact that blanching reduced drying time the most compared to all other analyzed methods.

scholarly journals Studies on the Catalytic Properties of Crude Freeze-Dried Preparations of Yarrowia lipolytica Extracellular Lipases for Geranyl Ester Derivative Synthesis

Biomolecules ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 839
Author(s):  
Karina Jasińska ◽  
Bartłomiej Zieniuk ◽  
Dorota Nowak ◽  
Agata Fabiszewska
Keyword(s):  
Freeze Drying ◽  
Antioxidant Properties ◽  
Antibacterial Properties ◽  
Synthetic Activity ◽  
Drying Process ◽  
Enzyme Preparations ◽  
Ester Derivative ◽  
Freeze Dried ◽  
The Impact ◽  
Geranyl Ester

The study aimed to evaluate the impact of selected factors of the freeze-drying process on the hydrolytic and synthetic activity of the extracellular lipases of Y. lipolytica KKP 379 and to attempt the use of the crude enzyme preparation as a biocatalyst in the synthesis of geranyl 4-hydroxyphenylpropanoate. Antioxidant and antibacterial properties of the geranyl ester derivative were also investigated in order to evaluate their usefulness as a novel food additive. The studies confirmed that freeze-drying was an effective method of dehydrating yeast supernatant and allowed for obtaining lyophilizates with low water activity from 0.055 to 0.160. The type and concentration of the additive (2–6% whey protein hydrolyzate, 0.5% and 1% ammonium sulphate) had a significant effect on the hydrolytic activity of enzyme preparations, while the selected variants of drying temperature during the freeze-drying process were not significant (10 °C and 50 °C). Low yield of geranyl 4-hydroxyphenylopropionate was shown when the lyophilized supernatant was used (5.3%), but the yield of ester synthesis increased when the freeze-dried Y. lipolytica yeast biomass was applied (47.9%). The study confirmed the antioxidant properties of the synthesized ester by the DPPH• and CUPRAC methods, as well as higher antibacterial activity against tested bacteria than its precursor with 0.125 mM MIC (minimal inhibitory concentration) against L. monocytogenes.

scholarly journals Freeze-drying microscopy in mathematical modeling of a biomaterial freeze-drying

2012 ◽  
Vol 48 (2) ◽  
pp. 203-209 ◽  
Author(s):  
Camila Figueiredo Borgognoni ◽  
Joyce da Silva Bevilacqua ◽  
Ronaldo Nogueira de Moraes Pitombo
Keyword(s):  
Mathematical Modeling ◽  
Freeze Drying ◽  
Drying Process ◽  
Critical Temperatures ◽  
Fundamental Properties ◽  
Moving Interface ◽  
Energy Consuming ◽  
Sublimation Rates ◽  
Time And Energy

Transplantation brings hope for many patients. A multidisciplinary approach on this field aims at creating biologically functional tissues to be used as implants and prostheses. The freeze-drying process allows the fundamental properties of these materials to be preserved, making future manipulation and storage easier. Optimizing a freeze-drying cycle is of great importance since it aims at reducing process costs while increasing product quality of this time-and-energy-consuming process. Mathematical modeling comes as a tool to help a better understanding of the process variables behavior and consequently it helps optimization studies. Freeze-drying microscopy is a technique usually applied to determine critical temperatures of liquid formulations. It has been used in this work to determine the sublimation rates of a biological tissue freeze-drying. The sublimation rates were measured from the speed of the moving interface between the dried and the frozen layer under 21.33, 42.66 and 63.99 Pa. The studied variables were used in a theoretical model to simulate various temperature profiles of the freeze-drying process. Good agreement between the experimental and the simulated results was found.

scholarly journals Effect of Supplementation of Dried Bioflocs Produced by Freeze-Drying and Oven-Drying Methods on Water Quality, Growth Performance and Proximate Composition of Red Hybrid Tilapia

2022 ◽  
Vol 10 (1) ◽  
pp. 61
Author(s):  
Tarq Binalshikh-Abubkr ◽  
Marlia Mohd Hanafiah
Keyword(s):  
Water Quality ◽  
Body Composition ◽  
Growth Performance ◽  
Freeze Drying ◽  
Energy Levels ◽  
Fish Growth ◽  
Drying Methods ◽  
Oven Drying ◽  
Freeze Dried

Supplementation of dried bioflocs for red hybrid tilapia (Oreochromis sp.) was examined during 57 days of feeding trials. Five experimental treatments; T1 (the control; without bioflocs), T2 (4% freeze-dried bioflocs), T3 (16% freeze-dried bioflocs), T4 (4% oven-dried bioflocs), and T5 (16% oven-dried bioflocs) were prepared to examine the water quality, growth performance and body composition of red hybrid tilapia. T2 and T4 treatments resulted in a higher growth rate and survival similar to the control, while T3 and T5 treatments showed the lowest values of growth performance among all treatments. T1 treatment showed the best quality of culture water followed by T2 and T4 treatments, while T3 treatment resulted in poor water quality followed by T5 treatment. Based on these results, the ratios of bioflocs (4% and 16%) had more effect on fish growth and water quality than the drying methods (freeze-drying and oven-drying). The ratio of 4% freeze-dried or oven-dried bioflocs provided higher growth rates and better water quality parameters similar to the control, while the ratio of 16% showed the worst growth performance and water quality in the present study. In addition, body compositions of tilapia fed 4% dried bioflocs showed better nutritional value than tilapia fed 16% dried bioflocs. Protein and energy levels showed an increasing trend with decreasing supplement levels of bioflocs. Moisture content was significantly higher when supplementation of 16% bioflocs was used. Overall, supplementation of 4% freeze-dried or oven-dried bioflocs can be successively included in red hybrid tilapia diets without any effects on growth or body composition and can result in a good quality of culture water for red hybrid tilapia.

scholarly journals Effect of lacto-fermentation and freeze-drying on the quality of beetroot evaluated using machine vision and sensory analysis

2021 ◽  
Author(s):  
Ewa Ropelewska ◽  
Anna Wrzodak ◽  
Kadir Sabanci ◽  
Muhammet Fatih Aslan
Keyword(s):  
Freeze Drying ◽  
Sensory Quality ◽  
Bitter Taste ◽  
Sensory Attributes ◽  
Discrimination Accuracy ◽  
Flatbed Scanner ◽  
Color Channel ◽  
Texture Parameters ◽  
Freeze Dried

AbstractThis study was aimed at evaluating the effect of freeze-drying and lacto-fermentation on the texture parameters of images and sensory attributes of beetroots. The samples were imaged using a flatbed scanner, and textures from images converted to color channels L, a, b, R, G, B, X, Y, Z were computed. The discrimination of raw and processed beetroots was performed using models based on textures selected for each color channel. The sensory quality of processed samples was determined using the attributes related to smell, color, texture and taste. The highest discrimination accuracy of 97.25% was obtained for the model built for color channel b. The accuracies for other channels were equal to 96.25% for channel a, 95.25% for channel R, 95% for channel Y, 94.75% for channel B, 94.5% for channel X, 94% for channel L, 92.5% for channel G, 88.25% for channel Z. In the case of some models, the raw and lacto-fermented beetroots were discriminated with 100% correctness. The freeze-dried and freeze-dried lacto-fermented samples were also the most similar in terms of sensory attributes, such as off-odor, attractiveness color, beetroot color, crunchiness, hardness, bitter taste, overall quality. The results indicated that the image parameters and sensory attributes may be related.

scholarly journals Effect of addition an amino acid or its combination with EDTA on DNA integrity and morphometry sperm heads of freeze-dried bovine spermatozoa

2020 ◽  
Vol 45 (3) ◽  
pp. 189-196
Author(s):  
S. Said ◽  
T. Maulana ◽  
S. Setiorini ◽  
G.E. Ibrahim ◽  
M.N. Ramadhan ◽  
...  
Keyword(s):  
Plasma Membrane ◽  
Amino Acid ◽  
Freeze Drying ◽  
Sperm Head ◽  
Test Method ◽  
Dna Integrity ◽  
Drying Process ◽  
Freeze Dried ◽  
Bovine Spermatozoa ◽  
Amino Acid Glycine

The objective of the current study was to investigate the effect of addition an amino acid or its combination with EDTA on DNA integrity and morphometry sperm heads of freeze-dried bovine spermatozoa. Spermatozoa were freeze-dried in medium with the addition of an amino acid glycine, cysteine, glutamine, or its combination with EDTA. Sperm head morphometry was identified at 400X magnification using Axio Vision(Zeiss Company, Germany), while for membrane plasma integrity (MPI) determined by calculation of the percentage of spermatozoa having intact plasma membrane by osmotic resistance test method and DNA integrity analysis using acridine orange staining. Sperm head had declined in size after the freeze-drying process, MPI of FD spermatozoa gradually increased significantly when FD solution was added with an amino acid solution (glycine, cysteine) and its combination with EDTA. DNA integrity of all freeze-dried spermatozoa treatments was remaining intact, no significantly different (P>0.01) among treatments. The present study concluded that the addition of an amino acid (glycine, cysteine) or its combination with EDTA could be reduced morphometric sperm heads and plasma membrane damage of freeze-dried bovine spermatozoa, however, DNA integrity of bovine sperm nucleus remaining intact after the freeze-drying process without addition both amino acids and EDTA. 

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